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dc.contributor.authorSparano, Joseph A.
dc.contributor.authorLee, Jeannette Y.
dc.contributor.authorPalefsky, Joel
dc.contributor.authorHenry, David H.
dc.contributor.authorWachsman, William
dc.contributor.authorRajdev, Lakshmi
dc.contributor.authorAboulafia, David
dc.contributor.authorRatner, Lee
dc.contributor.authorFitzGerald, Thomas J.
dc.contributor.authorKachnic, Lisa
dc.contributor.authorMitsuyasu, Ronald
dc.date2022-08-11T08:10:32.000
dc.date.accessioned2022-08-23T17:12:19Z
dc.date.available2022-08-23T17:12:19Z
dc.date.issued2017-03-01
dc.date.submitted2017-04-04
dc.identifier.citationJ Clin Oncol. 2017 Mar;35(7):727-733. doi: 10.1200/JCO.2016.69.1642. Epub 2016 Dec 12. <a href="https://doi.org/10.1200/JCO.2016.69.1642">Link to article on publisher's site</a>
dc.identifier.issn0732-183X (Linking)
dc.identifier.doi10.1200/JCO.2016.69.1642
dc.identifier.pmid27937092
dc.identifier.urihttp://hdl.handle.net/20.500.14038/46477
dc.description.abstractPurpose: Squamous cell carcinoma of the anal canal (SCCAC) is characterized by high locoregional failure (LRF) rates after definitive chemoradiation (CRT), associated with anogenital human papilloma virus, and often appears in HIV infection. Because cetuximab enhances the effect of radiation therapy in human papilloma virus-associated oropharyngeal SCC, we hypothesized that adding cetuximab to CRT would reduce LRF in SCCAC. Methods: Forty-five patients with stage I to III SCCAC and HIV infection received CRT: 45 to 54 Gy radiation therapy to the primary tumor and regional lymph nodes plus eight once-weekly doses of concurrent cetuximab and two cycles of cisplatin and fluorouracil. The study was designed to detect at least a 50% reduction in 3-year LRF rate (one-sided alpha, 0.10; power, 90%), assuming a 35% LRF rate from historical data. Results: The 3-year LRF rate was 42% (95% CI, 28% to 56%; one-sided P = .9) by binomial proportional estimate using the prespecified end point (LRF or alive without LRF and followed < 3 years), and 20% (95% CI, 10% to 37%) by Kaplan-Meier estimate in post hoc analysis using definitions and methods consistent with historical data. Three-year rates by Kaplan-Meier estimate were 72% (95% CI, 56% to 84%) for progression-free survival and 79% (95% CI, 63% to 89%) for overall survival. Grade 4 toxicity occurred in 26%, and 4% had treatment-associated deaths. Conclusion: HIV-associated SCCAC is potentially curable with definitive CRT. Although addition of cetuximab may result in less LRF, the 20% recurrence and 26% grade 4 toxicity rates indicate the continued need for more-effective and less-toxic therapies.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=27937092&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttps://doi.org/10.1200/JCO.2016.69.1642
dc.subjectHealth Services Administration
dc.subjectNeoplasms
dc.subjectOncology
dc.subjectRadiology
dc.titleCetuximab Plus Chemoradiotherapy for HIV-Associated Anal Carcinoma: A Phase II AIDS Malignancy Consortium Trial
dc.typeJournal Article
dc.source.journaltitleJournal of clinical oncology : official journal of the American Society of Clinical Oncology
dc.source.volume35
dc.source.issue7
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/qarc/3
dc.identifier.contextkey9974131
html.description.abstract<p>Purpose: Squamous cell carcinoma of the anal canal (SCCAC) is characterized by high locoregional failure (LRF) rates after definitive chemoradiation (CRT), associated with anogenital human papilloma virus, and often appears in HIV infection. Because cetuximab enhances the effect of radiation therapy in human papilloma virus-associated oropharyngeal SCC, we hypothesized that adding cetuximab to CRT would reduce LRF in SCCAC.</p> <p>Methods: Forty-five patients with stage I to III SCCAC and HIV infection received CRT: 45 to 54 Gy radiation therapy to the primary tumor and regional lymph nodes plus eight once-weekly doses of concurrent cetuximab and two cycles of cisplatin and fluorouracil. The study was designed to detect at least a 50% reduction in 3-year LRF rate (one-sided alpha, 0.10; power, 90%), assuming a 35% LRF rate from historical data.</p> <p>Results: The 3-year LRF rate was 42% (95% CI, 28% to 56%; one-sided P = .9) by binomial proportional estimate using the prespecified end point (LRF or alive without LRF and followed < 3 years), and 20% (95% CI, 10% to 37%) by Kaplan-Meier estimate in post hoc analysis using definitions and methods consistent with historical data. Three-year rates by Kaplan-Meier estimate were 72% (95% CI, 56% to 84%) for progression-free survival and 79% (95% CI, 63% to 89%) for overall survival. Grade 4 toxicity occurred in 26%, and 4% had treatment-associated deaths.</p> <p>Conclusion: HIV-associated SCCAC is potentially curable with definitive CRT. Although addition of cetuximab may result in less LRF, the 20% recurrence and 26% grade 4 toxicity rates indicate the continued need for more-effective and less-toxic therapies.</p>
dc.identifier.submissionpathqarc/3
dc.contributor.departmentDepartment of Radiation Oncology
dc.contributor.departmentQuality Assurance Review Center
dc.source.pages727-733


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